“Intranasal toxicity studies of zavegepant were conducted in Sprague Dawley rat (4-, 13-, and 26-week) and cynomolgus monkey (4-, 13-, and 39-week).”
✓ VerifiedFDA pharmacology/toxicology review, p. 3Source ↗
Pivotal GLP studies
26-week rat and 39-week cynomolgus monkey intranasal studies
“Intranasal toxicity studies of zavegepant were conducted in Sprague Dawley rat (4-, 13-, and 26-week) and cynomolgus monkey (4-, 13-, and 39-week).”
✓ VerifiedFDA pharmacology/toxicology review, p. 3Source ↗
Route in tox
Intranasal; additional subcutaneous studies to increase systemic exposure
“Because systemic exposure was low (“generally <2%”) following IN dosing, additional studies were conducted using subcutaneous administration to increase systemic exposure (4- and 13-week in rat; 4-week in monkey).”
✓ VerifiedFDA pharmacology/toxicology review, p. 3Source ↗